Somatex Medical Technologies GMBH Recall 87317
Description: Thread-like wire marker
Somatex Medical Technologies GMBH Recall 87317 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1200-2021 |
Event ID | 87317 |
Event Description | Thread-like wire marker |
Product Type | Devices |
Distribution | Domestic: Mo, NJ, OH |
Quantity | 196 pieces |
Recall Reason | This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body. |
Device Classification | 20210317 |
Device Code Info | Tuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270, 51411; REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300; REF 271651 Affected Lots: 51299, 51413; REF 271652 Affected Lots: 51301. |
Center Classification Date | 20210310 |
Recall Initiation Date | 20210203 |
Recalling Firm | Somatex Medical Technologies GMBH |
Initial Notification | |
Similar To |